Electrical stimulation for foot drop in people with multiple sclerosis (MS)

Training Effect of Peroneal Nerve Stimulation on Fatigue Induced Gait Variability in People with Multiple Sclerosis.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000201875

Enrollment

Registered

2012-02-17

Start date

2011-05-13

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This research study aims to test how effective the BioNessL300 is on fatigue induced gait variability in people with MS. In this study participants will wear a commercially available peroneal nerve stimulator (NessL300) for 8 weeks. The first 3 weeks will consist of training and acclimatisation to the device, starting at 15 minutes per day, building up to 8 hours of use per day. Participants will then continue to use the device as an orthosis for the next 5 weeks.

Interventions

Patients will wear a commercially available peroneal nerve stimulator (NessL300) for 8 weeks. The first 3 weeks will consist of training and acclimatisation to the device, starting at 15 minutes per day, building up to 8 hours of use per day. They will then continue to use the device as an orthosis for the next 5 weeks using it for 8 hours per day. All participants will be provided with a 3 week training sheet that explains how long they wear the device for each day.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Subjects fulfilling the following inclusion criteria will be identified and recruited for the study: - Definite Diagnosis of MS - Mild to moderate difficulty in mobility with EDSS score 3.5 - 5.0 - Able to walk 100m without the use of walking aids - Notice difficulty clearing one foot more than the other when stepping, which worsens the further they walk - Ability to understand instructions and give informed consent

Exclusion criteria

The exclusion criteria include: - Exacerbation/Relapse of MS - Use of medication prescribed for Fatigue e.g. Amantadine, Modafinil - Significant Cardiac or respiratory disease - Severe depression - Severe arthritis, fibromyalgia or pain with walking - Regularly use an AFO with walking - A demand-type pacemaker, defibrillator or any electrical or metallic implant - A cancerous lesion is present or suspected - Presence of regional disorders, such as a fracture or dislocation, which would be adversely affected by motion from the stimulation

Outcome results